Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to the identity and operational standards of the pharmacy located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, this pharmacy adheres to rigorous federal standards for quality control, sterility, and safety that exceed those of traditional compounding pharmacies. The primary function of a 503B compounding pharmacy is the large-scale compounding of medications, which are then distributed to healthcare providers for office use and patient administration. This facility provides a critical service by producing medications that are often in short supply or unavailable from conventional manufacturers.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are defined by its status as a 503B outsourcing facility. This includes the compounding of sterile injectable medications, which are essential for a wide range of medical treatments and procedures performed by local healthcare practitioners. The pharmacy’s operations are focused on non-patient-specific, office-use compounding, meaning the medications are prepared in advance for healthcare providers to have on hand for immediate use with their patients. This model ensures that practitioners at local clinics and medical offices have reliable access to high-quality, essential medications without the delays associated with traditional ordering channels.
Quality and compliance are the cornerstones of the operation at 2160 W State Road 434, Longwood, FL 32779. The facility follows current Good Manufacturing Practices (cGMP), which are enforced by the FDA. This involves stringent environmental controls, comprehensive testing of components and finished products, and meticulous documentation of every step in the compounding process. For healthcare providers, this means that every medication received from this 503B compounding pharmacy meets the highest possible standards for potency, purity, and sterility. The commitment to these protocols ensures patient safety and provides practitioners with complete confidence in the medications they use.
The team at 503B Compounding Pharmacy comprises highly trained pharmacists, pharmacy technicians, and quality assurance professionals who are dedicated to the science and safety of pharmaceutical compounding. Their expertise ensures that all processes from formulation to final packaging are executed with precision. The pharmacy at 2160 W State Road 434, Longwood, FL 32779 serves as a vital partner to the local medical community, providing a dependable source for critical medications. For more information about its services or to inquire about becoming a client, you can visit the website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that this is a 503B compounding pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large volumes of sterile, non-patient-specific medications for office use by healthcare practitioners, adhering to strict federal quality standards.
Who can receive medications from this 503B compounding pharmacy?
Medications compounded at this location are distributed to licensed healthcare practitioners and medical facilities for administration to patients within their practice. This 503B compounding pharmacy does not dispense medication directly to individual patients.
What types of medications are compounded at this location?
The 503B compounding pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in the compounding of sterile injectable medications, which are provided to local healthcare providers for use in their practices.
How does the quality assurance process work at this facility?
This 503B compounding pharmacy operates under current Good Manufacturing Practices (cGMP) as required by the FDA. This includes rigorous environmental monitoring, sterility testing, and potency verification for all medications produced at the Longwood location.
How can a local healthcare provider place an order?
Healthcare providers interested in the services of this 503B compounding pharmacy can initiate the process by contacting the facility directly at (407)993-1381 or by visiting the website at https://503bcompoundingpharmacy.com/ for more information.